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Intermittent dieting may reverse early heart risks in kids

NCT ID NCT06500078

Disease control Sponsor: Children's Hospital of Fudan University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This trial tests whether intermittent dietary restrictions—either low-carb or calorie-restricted diets on two days per week—can reverse early signs of heart and metabolic problems in school-aged children aged 7 to 18. Participants have at least one risk factor like prediabetes, abnormal cholesterol, or high blood pressure. The study compares these diets to standard health education to see if they can improve children's cardiometabolic health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
intermittent dietary restriction (low-carb or calorie-restricted diet)
What this could lead to
If it works, this could offer a simple, non-drug way to reverse early signs of heart and metabolic problems in children.
What could go wrong
This is a relatively small, early-stage trial. Dietary restrictions can be hard to stick to, and results may not apply to all children. Long-term effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 324 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

7 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged 7-18 years at baseline. * At least one of the following cardio-metabolic abnormalities: 1. Prediabetes (Impaired fasting glucose: 5.6 ≤ fasting blood glucose level ≤ 6.9 mmol/L; or Impaired glucose tolerance: 7.8 ≤ blood glucose level after 2 hours postprandial ≤ 11.0 mmol/L). 2. Lipid abnormalities (High-density lipoprotein cholesterol ≤ 1.04 mmol/L; or Low-density lipoprotein cholesterol ≥ 3.37 mmol/L; or Triglycerides ≥ 1.70 mmol/L, or Total cholesterol ≥ 5.18 mmol/L). 3. Elevated blood pressure (Systolic/diastolic blood pressure consistently higher than the 90th percentile for gender, age, and height; or systolic/diastolic blood pressure ≥ 120/80 mmHg). Exclusion Criteria: * Previously diagnosed with heart failure, severe malnutrition, immune deficiency, liver or kidney disease, cancer, or other diseases deemed unsuitable for participation. * Had a history of bariatric surgery. * Used weight loss pills or supplements in the last three months. * Other situations unsuitable for participation.

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome hypertensive disorder inherited lipid metabolism disorder metabolic syndrome X prediabetes syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular syndrome, metabolic

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Children's Hospital of Fudan University

    RECRUITING

    Shanghai, China

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